Composition

Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores soaked on a strip (spores carrier). It also has purple colored culture medium contained within the glass ampoule, next to the carrier, on the base of the tube.

Product description

Bionova® BT95 Rapid Readout Biological Indicators have been designed for quick and easy monitoring of Plasma or Vaporized Hydrogen Peroxide sterilization cycles. They consist of a plastic tube, a spore carrier and a glass ampoule with culture medium. The tube has a plastic top with holes and a barrier permeable to Hydrogen Peroxide.

Rapid readout: 2 hours

The Rapid Readout must be carried out in the Bionova® IC10/20FR, Bionova® IC10/20FRLCD or Bionova® MiniBio reader Incubator or in a similar reader Incubator that meets the requirements that are described next. The reader-incubator must be capable of reading the fluorescence emission of the product, resulting from breaking a specific substrate on the spore carrier. Fluorescence is produced when the reader excites the carrier with UV light at 360 nm. Final reading of negative results is readily available at 2 hours of incubation. Fluorescence is a direct process of the germination and growth of
Geobacillus stearothermophilus spores which have survived the sterilization process (positive result). Furthermore, a failure in the sterilization process can also become evident by the color change of the medium.

Final fluorescence reading is performed after 2-hour incubation at 60
ºC (sensitivity: 97 %).

An optional visual pH color change confirmation could be performed
after 48 hours of incubation. If sterilization process has not been
successful, culture medium will change to a greenish color first, and
then to yellow during incubation at 60 ºC, thus showing the presence
of living spores. If sterilization process is successful culture medium
will remain purple after the incubation process.

7-day readout is optional and not intended to be routinely performed; it
is an initial validation of the 2-hour reading. Fluorescence results may
be compared to the 7-day visual reading.